Litigation Involving Drug Patents in Recent Years: Case Sharing (II)

When the number of patent registrations in the field of biotechnology increases and the implementation of relevant policy responses can promote the positive development of innovation and drug research and development. Through patent protection, companies and research institutions can ensure that their research results and drug innovations are legally protected. And gain a competitive advantage in the market, which is not only of great significance to economic development, but also contributes to the progress and cooperation in the global biotechnology field.

The Russian Patent Office aims to optimize the task of providing government services in the digital environment and is committed to shortening the time for examination of applications. In the digital economy environment, business development needs to speed up the relevant processes, only in2018years, the average time to review an invention application was shortened1.19At the end of the year, the average was8.05months; the examination time for trademark applications is shortened.1.39At the end of the year, the average was7.5months, this trend in2019The average time for the review of invention applications was also maintained in the first quarter6.5months, for trademarks.6.25In addition, the Russian Patent Office offers a paid option to accelerate the procedure for the examination of applications for the registration of intellectual property rights, which can be shortened.2Months.

On the other hand, Russian drug manufacturers continue to issue patents granted to new drug manufacturers, with the goal of not having to wait for the deadline set by the Russian Patent Office to start producing generic drugs, which is particularly common in oncology drugs.

For example, Astelicom Pharmaceuticals(AstraZeneca plc.)AlreadyGefinibPatented, the drug is used to treat tumors, however the Indian companyYoung Expoim Pvt. Ltd.Branches of RussiaLLC "Young Expoim"Registered in the National Register containingGefinibthe maximum selling price of the substance of the drug,AstraZenecaconsidered to have infringed its patent rights and filed a claim with the Moscow Arbitration Court (Case No:A40-106405/2018)file a lawsuit to prohibitYoung ExpoimThe new drug into the market circulation, the plaintiff said that the registration is to prepare the sale of drugs, however, the court of first instance rejectedAstraZenecaThe claim points out the lack of direct evidence that the disputed product was put on the market.

AstraZenecaThis was appealed, however, the Court of Appeal disagreed with the original conclusion, requiringYoung ExpoimTo the Ministry of Health of the Russian Federation(Ministry of Health of the Russian Federation)Make a revocation application to cancel the drugGefiniband its maximum selling price, the Ninth Court of Appeal explained that the drug was registered primarily for the purpose of putting it on the market, and the Court held thatYoung Expoimthe conduct of the plaintiffAstraZenecaPatented substancesGefinibThe pre-sale of the drug infringed the plaintiff's patent rights, and the intellectual property court agreed to the appeal.

Young ExpoimA subsequent complaint was made to the Supreme Court, where the company maintained that registration did not serve as evidence of the preparation of the sale and therefore could not be regarded as a reference toAstraZenecathe threat of patent rights,Vladimir Popov.The judge agreed with the decision of the appeal and the decision of the Intellectual Property Court after reviewing the case information and approved the decision. The applicant's argument cannot deny the correctness of the court's conclusion, nor can it be a sufficient basis for revisiting the court's decision in the appeal procedure. Therefore, the Supreme Court refused to accept the complaint. This is the first time that the Supreme Court has supported the decision to revoke the approval of generic drugs due to patent infringement.

The average pharmaceutical company needs to invest about30The exclusive right of patents allows pharmaceutical companies to sell their research and development results on the market alone during the patent period. Such patent protection measures help encourage pharmaceutical companies to invest in new research and development.